13 ago
|
Premier Research
|
España
13 ago
Premier Research
España
Premier Research is looking for a Statistical Scientist Director to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Serve as lead statistician on complex, key client studies, acting as point-of-contact, ensuring cohesive communication with sponsors and internal teams, and leading project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.
Develops or provides senior oversight for statistical deliverables, including:
Statistical Analysis Plans (SAPs)
Independently develop SAS/R programs as needed.
Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies.
Acts as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations.
Oversee cross-project statistical consistency, supporting portfolio-level scientific strategy when applicable.
Advise clients on regulatory guidelines, statistical principles for submissions, and integral expectations (FDA, EMA, PMDA, etc.).
Keeps up with new and upcoming statistical techniques as well as regulatory authority developments, mentors and trains department members, and support the development and maintenance of departmental training, SOPs and guidelines.
Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
~15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment.
~ At least 1 yr technical experience in clinical trials design and analysis implemen
📌 Statistical Scientist Director (España)
🏢 Premier Research
📍 España